Recall Z-1520-06 · LZU Plug, Punctum
Oasis Medical Inc
OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E)
| Date | Sep 23, 2006 (initiated Jul 6, 2006) |
| Status | Terminated |
| Reason | Labeled with an incorrect diameter |
| Root cause | Package design/selection |
| Action | OASIS Medical informed all customers via FAX and Certified Mailt that received the product that the firm was voluntarily recalling one lot of the SOFT PLUG Extended Duration Plugs (REF 6403) and to cease use immediately. Customers are advised to check their inventory and return any remaining and return all unused product to OASIS Medical SOFT PLUG Extended Duration Plugs (REF 6403) from Lot LA1105E by FedEx. Customers are also advised that if they have used the product, to inform OASIS Medical of the number of samples of this lot used for an accurate account of the product distributed, us |
| Quantity | 1,212 SOFT PLUG¿ Extended Duration Plug pouches of Lot LA1105E. Each pouch contains 2 plugs. |
| Distribution | Worldwide distribution ----USA and countries of Chile, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013613 | SOFT PLUG ABSORBABLE PLUG-SA Oasis Medical, Inc., Jun 27, 2002 |